A transobturator implant patient’s product liability claims against the manufacturer were time-barred by Maine’s six-year statute of limitations because her injuries were not the result of a condition that was covered by the continuing tort doctrine exception, a federal district court in Maine ruled in granting summary judgment to the manufacturer. Furthermore, she did not establish causation for her failure-to-warn claims because she did not show that her doctor would not have used the device had he known all of the risks associated with the product (Novak v. Mentor Worldwide LLC, February 14, 2018, Torresen, N.).

Background. In 2004, the patient underwent surgery in Maine to implant an ObTape™ to relieve her problems with urinary incontinence. Prior to her surgery, her doctor advised her generally of the complications that could result with implanting a foreign device, but did not recall any discussion about the complications that could result specifically from the ObTape. After the surgery, the patient experienced painful symptoms and underwent tests which proved inconclusive. The patient stopped the testing after the first round due to embarrassment, and did not receive a diagnosis. In 2014, the patient underwent surgery to remove part of the ObTape, and then filed suit against the manufacturer in 2016. The manufacturer filed a motion for summary judgement alleging that her claims of negligence, defective design, manufacturing defects, failure-to warn, breach of implied warranties, breach of express warranties, and negligent misrepresentation were time-barred under Maine’s six-year statute of limitations and that she failed to prove causation for her failure-to-warn claims.

Statute of limitations. The statute of limitations law in the state of Maine requires all claims to be brought within six years of the date that the cause of action accrued, or the time when the act produced an injury that would entitle the patient to seek judicial action. The patient had filed her cause of action on January 14, 2016, and, so, the manufacturer argued that any injury that occurred before January 14, 2010 would be barred by the statute of limitations. The patient argued that the continuing tort doctrine exception applied in this case, in that the device was a condition that caused harm to her throughout the time it was implanted within her. The court rejected the argument from the patient, stating that she did not allege repeated actions but a set of acts which led to her injuries. Although she had ongoing harm, the statute of limitations began to run in 2004 when she experienced her first set of symptoms. The court also rejected her argument that there was a dispute over whether her symptoms in 2004 through 2006 were actually caused by the device. No evidence was presented to the court that proved that her symptoms could be from something other than the implantation of the ObTape, and the manufacturer presented evidence that the device was the cause of her early symptoms.

Causation. The court agreed with the manufacturer’s argument that the patient failed to demonstrate causation for her failure-to-warn claims. To demonstrate causation, the patient had to show that that the manufacturer had failed to warn about the product, and this failure was the proximate cause of her injuries. In this case, the doctor had implanted the device in the patient and the manufacturer would be absolved from liability if it had adequately warned the physician of the risks. Even though the learned intermediary rule applied, which would require demonstrating that an adequate warning would have prevented the product from being implanted, the patient failed to produce evidence that the doctor would not have used the device had he been informed about all the risks associated with the ObTape. Although she produced articles that discussed the ObTape and suggested that it had more issues that other products, she could not prove causation because she did not provide any evidence that this information would have changed the decision to implant the device.

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